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U.S. Department of Health and Human Services

Class 3 Device Recall Visitec

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 Class 3 Recall
Visitec
see related information
Date Posted March 29, 2007
Recall Status1 Terminated on March 05, 2008
Recall Number Z-0672-2007
Recall Event ID 37533
Product Classification Device, Irrigation, Ocular Surgery - Product Code KYG
Product BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618
Code Information Lot Number: 6181868
Recalling Firm/
Manufacturer
Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham, Massachusetts 02452-8448
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact David Cromwick
781-906-7950
Manufacturer Reason
for Recall
Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.
Quantity in Commerce 1500 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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